MAUDE Adverse Event Report: CIRCULATORY TECHNOLOGY, INC. THE BIGGER BETTER BLADDER; BIGGER BETTER BLADDER (BBB38)

Model Number	BBB38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As previously stated, all better bladder products are visually inspected and tested during manufacturing.The lot was manufactured by contract manufacturer, dg medical, and met all acceptance criteria.Two additional units from the same manufacturing lot were tested and found acceptable.The user states that the bigger better-bladder (bbb38) failed due to the bladder collapsing.This product lot was manufactured with an improved bond between the tubing and the housing and this is the first complaint of a collapsing bbb38.Unfortunately, the units were not returned to the cti and hence it was not possible to validate the failure nor determine the cause of the failure.Potential root cause: the collapse may have been due to a poor connection anywhere between the pigtail and the pressure transducer (e.G.Numerous stopcocks and numerous luer fittings).This is a user error and could not be confirmed.Conclusion: the product concern could not be confirmed by cti.There have been no other complaints for this manufacturing lot, or for this failure mode since implementation of corrective action.
Event or Problem Description
On 2/24/2020, hospital notified manufacturer that two bigger better-bladders, model bbb38, began to collapse within 24 hours of clinical use.The first bbb38 started to collapse upon ecls initiation on (b)(6) 2020.The 2nd collapsed 12 hrs after a circuit change on (b)(6) 2020.They kept collapsing and were changed with a bbb38 from another lot.The products were used on the same patient.The units were replaced and there was no harm or adverse effect to the patient.

• Brand Name: THE BIGGER BETTER BLADDER
• Common Device Name: BIGGER BETTER BLADDER (BBB38)
• Manufacturer (Section D): CIRCULATORY TECHNOLOGY, INC.; 21 singworth street; oyster bay, ny
• MDR Report Key: 9879086
• Report Number: 1000522036-2020-00001
• Device Sequence Number: 11357660
• Product Code: DTN
• UDI-Device Identifier: 00851997007011
• UDI-Public: (01)00851997007011(10)5300T20265(17)210802(11)180802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: BBB38
• Device Catalogue Number: BBB38
• Device Lot Number: 5300-T20265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Weight: 18